Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
研究概览
简要总结
Alcohol use disorders are among the most prevalent mental disorders in Canada; however, due to numerous barriers, including fear of treatment, privacy concerns, stigma, time conflicts, and lack of availability of treatment, less than 10% of people with alcohol dependence receive treatment. Accordingly, there is a need to expand treatment coverage for alcohol use disorders, especially for populations which face barriers to receiving treatment.
The objective of this proposed project is to develop a digital health worker, named PAHOLA, which can effectively deliver interventions to people who would not otherwise receive such treatment. To achieve this objective, the following research aims will be addressed:
- To develop a digital human-based intervention that can initiate change processes and reduce alcohol use by applying the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT) in a credible manner.
- To assess the impact of the virtual care provided by PAHOLA on health outcomes using a randomized controlled study design (RCT) to assess potential effect sizes for a larger future RCT.
If successful, the PAHOLA project has the potential to transform our ability to prevent alcohol-attributable harms in Canada by promoting health, health equity, and well-being, especially among those people who do not normally receive treatment for harmful alcohol use.
详细描述
Alcohol use disorders are among the most prevalent mental disorders in Canada; however, due to numerous barriers, including fear of treatment, privacy concerns, stigma, time conflicts, and lack of availability of treatment, less than 10% of people with alcohol dependence receive treatment. Accordingly, there is a need to expand treatment coverage for alcohol use disorders, especially for populations which face barriers to receiving treatment.
.
The objective of this proposed project is to tailor PAHOLA into a digital health worker which can effectively deliver BIs to people who would not otherwise receive such treatment. To achieve this objective, the following research aims will be addressed:
-
To develop a digital human-based intervention that can initiate change processes and reduce alcohol use by applying the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT) in a credible manner.
-
To assess the impact of the virtual care provided by PAHOLA on health outcomes using a randomized controlled study design (RCT) to assess potential effect sizes for a larger future RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current drinkers 18 years of age and older who score 7 to 23 on the Alcohol Use Disorders Identification Test
- •Use of medication to treat harmful alcohol use will be allowed provided that the dose has been stable for 8 weeks
- •Availability of a computer with a connection to the internet and a camera and microphone
排除标准
- •A history of drug use disorders (other than alcohol) in the last two years (except tobacco use disorder)
- •Dose changes of concomitant medications will not be permitted during the study period
- •Pregnant or lactating women, and women of childbearing potential who are not using medically accepted forms of contraception, or women who are planning on becoming pregnant during the study time frame
- •People who are currently reciving psychological treatment for alcohol use disorders
结局指标
主要结局
Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
时间窗: 6 months
Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
Changes in alcohol use quantity
时间窗: 6 months
Alcohol use quantity (measured in average grams per day in the past week)
Changes in alcohol use frequency
时间窗: 6 months
Alcohol use frequency (measured in drinking days in the past week)
次要结局
- Changes in quality of life(6 months)
- Packs of cigarettes smoked in the past week(6 months)
- Changes in depression(6 months)
- Changes in anxiety(6 months)
研究者
Jurgen Rehm
Senior Scientist
Centre for Addiction and Mental Health